MAUDE Adverse Event Report: INTUITIVE SURGICAL, INC ENDOWRIST;DAVINCI SI; LARGE HEM-O-LOK CLIP APPLIER

Model Number	420230-09
Medical Device Problem Codes	Material Frayed (1262); Difficult to Open or Close (2921)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	11/06/2020
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The large hem-o-lok clip applier instrument has been returned and evaluated by the failure analysis team.Failure analysis investigations confirmed the customer reported complaint of "instrument endowrist wire was broken." failure analysis found the primary failure of a frayed grip cable at the distal end.The frayed cable strands stuck out at the wrist.Root cause of this failure is attributed to a component failure.Failure analysis found the secondary failure of failed clip test.The instrument was placed and driven on an in-house system.The instrument passed the recognition and engagement tests.The instrument moved intuitively with full range of motion in all directions.The grips clip test was performed and failed.The clip was unable to successfully clip onto the tubing during in-house testing.
Event or Problem Description
It was reported that during a da vinci-assisted total hysterectomy - malignant surgical procedure, the large hem-o-lok clip applier instrument wire was broken.A backup instrument was used.The procedure was completed with no reported injury.

• Brand Name: ENDOWRIST;DAVINCI SI
• Common Device Name: LARGE HEM-O-LOK CLIP APPLIER
• Manufacturer (Section D): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer (Section G): INTUITIVE SURGICAL, INC; 3410 central expressway; santa clara CA
• Manufacturer Contact: izabel nielson ; 3410 central expressway; santa clara, CA ; 4085232100
• MDR Report Key: 16926731
• Report Number: 2955842-2023-13256
• Device Sequence Number: 17872742
• Product Code: NAY
• UDI-Device Identifier: 00886874111680
• UDI-Public: (01)00886874111680(10)N10180710
• Combination Product (Y/N): N
• Initial Reporter Country: TW
• PMA/510(K) Number: K050369
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Other,Foreign,Company Representative
• Initial Reporter Occupation: Non-Healthcare Professional
• Remedial Action: Other
• Type of Report: Initial
• Report Date (Section B): 11/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 420230-09
• Device Catalogue Number: 420230
• Device Lot Number: N10180710 207
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/18/2020
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 11/25/2020
• Initial Report FDA Received Date: 05/13/2023
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/09/2018
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• If action reported to FDA under 21 USC 360i(g), list FDA-assigned Recall Number or include a statement: N/A
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DA VINCI INSTRUMENTS AND ACCESSORIES
• Patient Sex: Unknown